By Carla Reed, president, New Creed LLC
The road from discovery of a promising molecule through the stages of clinical trials and final approval can be a challenging one. The rewards, however, are great — bringing a life-saving drug product to the point where it fulfills the promises of the early days of exploration cannot be overstated!
The journey may take years, during which there are many different players who have roles to fulfill. Suppliers of the materials and equipment to the laboratory where the first discovery is made are in many cases replaced by larger players with capabilities to provide a broader range of materials, services, and support. In many cases, even the team of scientists who were key in the initial stages will be replaced by experts in larger-scale production, in preparation for scaling up to a sustainable commercial supply model. A twist on this is the increasing trend to outsource the majority of these activities to contract research and manufacturing organizations, creating a virtual operation that requires collaboration and ongoing communication.
During this evolution there are many lessons to be learned, not the least of which is that it is imperative to take into account the nuances of supply chain management that can make the difference between success and failure. The ultimate prize — delivering the life-saving (or life-changing) substance to the point of care — takes careful planning, leaving no stone unturned, to ensure that risk factors are evaluated and a clearly defined strategy is in place.
The first step on the path to delivering a successful commercial supply chain strategy is to review the business strategy, ensuring that all elements of the storage and distribution network align with the mission and business goals of the enterprise and, more importantly, with the needs of caregivers and patients.
At a high level, the following are important factors that need to be evaluated and integrated into the plan.
- Access to therapy and availability through preferred channels – Many new biological and pharmaceutical products are administered in a clinical environment, with either in-patient or out-patient settings. Distribution models should support the current acquisition channel for related therapies, ensuring access to the product for providers and the patients they administer to.
- Inventory staging prior to commercial release – Demand planning should include identification of quantity and location for placement and replenishment of inventory to support projected demand and delivery channels once the product has been approved and orders are filled.
- Service and supply – Order fulfillment models should be developed and refined to ensure that new therapies can be acquired in a timely and cost-effective manner, enhancing the overall provider and patient experience.
- Regulatory compliance – Awareness and understanding of guidelines and regulations for the storage and distribution of pharmaceuticals are critical. This includes compliance with regulations (current and planned) that should be adhered to in order to ensure the authenticity, safety, and security of the product.
Elements of the strategy to transition from an exploratory stage to a clinical one, and finally to a commercial supply chain, should include the following eight elements.